The Recall Desk
CriticalFDA (Drugs)·D-1332-2014·Announced 2014-05-28

Esbelder Man Herbal Blend Recalled for Undeclared Sibutramine

Herbal Give Care Llc is recalling Esbelder Man Herbal Blend because it contains undeclared sibutramine, a drug removed from the U.S. market for safety reasons.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classified this recall as Class I, which corresponds to a Critical severity score per the rubric.

Plain-English summary

Herbal Give Care Llc is recalling 195 bottles of Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottles. The product was manufactured in Mexico by Soluciones S. de R.L. de C.V. and distributed nationwide to distributors, with some product sold directly to consumers.

The recall was initiated because the product was found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. Sibutramine was previously removed from the U.S. market for safety reasons, which makes these products unapproved new drugs.

Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.

The recalled product

Product
Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Herbal Give Care Llc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →